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Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial.

Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial. - MISOS trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50599
Enrollment
184
Registered
2014-08-15
Start date
2015-07-21
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spondylolisthesis vertebral slippage

Interventions

Minimally invasive spondylodesis versus conventional open spondylodesis.

Sponsors

neurochirurgie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age between 18 and 75 years. * Neurogenic claudication or radicular leg pain with or without low back pain. * Degenerative or spondylolytic spondylolisthesis grade I or II with spinal stenosis. * Persistent complaints for at least 3 months, regardless conservative treatments. * Be able to understand the Dutch language and comprehend the questionnaires and patient information. * Written informed consent given.

Exclusion criteria

Exclusion criteria: * Previous spine fusion surgery at the same level. * More than 1 symptomatic level that need fusion. * Osteoporosis. * Active infection or prior infection at the surgical site. * Active cancer. * Contraindication for surgery. * Severe mental or psychiatric disorder. * Alcoholism. * Morbid obesity (BMI > 40). * Pregnancy. * Inadequate knowledge of Dutch language.

Design outcomes

Primary

MeasureTime frame
Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100 mm) at 2 and 6 weeks after surgery.

Secondary

MeasureTime frame
Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire for Sciatica (RMDQ), self perceived recovery according to the patient (Likert), VAS leg pain, quality of life (EQ-5D), re-surgery, complications, and fusion (evaluated on CT).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)